Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC)

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT06361043

Studienbeginn:
April 2024

Letztes Update:
25.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Insel Gruppe AG, University Hospital Bern

Collaborator:
-

Studienleiter

Hossein Hemmatazad, MD
Study Chair
Inselspital Bern, Department of Radio-Oncology

Kontakt

Hossein Hemmatazad, MD
Kontakt:
Phone: +41 31 632 26 32
E-Mail: Hossein.Hemmatazad@insel.ch» Kontaktdaten anzeigen

Timo Nannen
Kontakt:
Phone: +41 31 632 90 74
E-Mail: timo.nannen@insel.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Inselspital, University of Berne, Deparftment of Radio-Oncology
3010 Berne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Hossein Hammatazad, MD
Phone: +41 31 632 26 32
E-Mail: hossein.hemmatazad@insel.ch

Timo Nannen
Phone: +41 31 632 90 74
E-Mail: timo.nannen@insel.ch» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Esophageal cancer (EC) is currently the tenth most common cancer and sixth leading cause of

cancer-related mortality worldwide. Multimodal treatment strategy consisting of surgery with

pre-/perioperative Radio-/chemotherapy (RCHT) regimens the standard of care for

non-metastatic locally advanced EC. However, the treatment of EC is challenging and the risk

of tumor recurrence remains high. Furthermore, toxicities of such combined treatments can be

substantial and there is room for optimization of RT to reduce the radiation dose to heart

and lungs. While 3D-conformal radiotherapy is traditionally used for treatment of EC, modern

irradiation techniques, such as intensity-modulated radiotherapy (IMRT) or volumetric

intensity modulated arc therapy (VMAT), are increasingly implemented in the management of EC.

The investigators know from literature that esophageal motion could be a challenge and

therefore bigger margins are needed to achieve an acceptable tumor coverage. In addition to

positioning and motion uncertainties, there could be a substantial inter-fractional tumor

size reduction during RCHT. Tumor shrinkage can consequently lead to OARs shifting into the

target volumes, which results in excess radiation dose to OARs with increased toxicity.

Adaptive radiotherapy (ART) is a treatment technique to do a re-planning during the course of

treatment to adjust the delivery of radiation dose based on geometrical changes of tumor and

OARs. Considering the uncertainties in OAR and tumor displacement positioning, as well as

tumor size reduction during RCHT, makes EC a perfect candidate for ART. This single-arm

prospective study aims to assess pulmonary toxicity and dosimetrical analysis of ART for EC.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Written informed consent

- Histologically confirmed diagnosis of AC (Adenocarcinoma) or SCC (squamos cell

carcinoma) of the thoracic esophagus or gastroesophageal junction (Siewert I-II)

- Patients with cT2-4b cN0 cM0 or cTany cN+ cM0 or any patient with early stage EC

ineligible for upfront surgery

- Age >= 18 years old

- Karnofsky Performance Status (KPS) >= 70 or ECOG (Eastern Cooperative Oncology Group)

0 - 1

- Absence of any psychological, familial, sociological or geographical condition

potentially hampering compliance with the study protocol and follow-up schedule; those

conditions should be discussed with patients before registration in the trial

Exclusion Criteria:

- Cervical esophageal cancers (15-18 cm from the incisors)

- Definitive clinical or radiologic evidence of metastatic disease

- Any active malignancy within 2 years of study registration that may alter the course

of esophageal cancer treatment

- Prior thoracic radiotherapy that would result in overlap of radiation therapy fields

- Induction chemotherapy for the current malignancy prior to RCHT is allowed if last

dose is no more than 90 days and no less than 10 days prior to registration

- Pregnant and/or breast-feeding females

Studien-Rationale

Primary outcome:

1. Number of patients with pulmonary toxicity (Time Frame - Up to 12 months after RCT):
The primary endpoint of this prospective study is pulmonary toxicity after concurrent radio-chemotherapy for patients with esophageal cancer treated with ART. According to literature, around 10 - 25%- of EC patients experience radiation induced pulmonary complications (RIPC) after combined radio-chemotherapy. However, the high rates of toxicity (up to 25%) were seen in patients irradiated with old RT techniques, such as 3D-CRT (Conformal Radiotherapy). New data, using modern RT, show much less pulmonary toxicity (10%). RIPC includes mostly radiation pneumonitis, radiation pulmonary fibrosis and pleural effusion .

Secondary outcome:

1. Number of patients with pathological complete response (Time Frame - Directly after surgery up to two weeks):
A pathological complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with RCHT. To find out if there is a pCR, a pathologist checks the tissue samples to see if there are still cancer cells left after the anticancer treatment.

2. Dosimetrical analysis between scheduled and adaptive plans (Time Frame - Directly after radiotherapy up to two weeks):
Dosimetrical analysis between scheduled and adaptive plans. We set the dosimetric goals for target volumes and OARs as follows: CTV coverage: D95% >= 100.0%* PTV coverage: D95% >= 100.0% PTV Dminimum: D99% >= 99.0% PTV Dmaximum: D1.0% <= 101.0% Heart: Dmean < 18Gy° Lung: V20Gy < 20% and mean lung dose (MLD) < 12Gy - Liver: Dmean < 18Gy" Dose that covers 95% of target volume is equal or more than 100% of prescribed dose. "Mean Dose to the heart should be less than 18Gy "Mean dose to the liver should be less than 18Gy All these values will be extracted from treatment planning system (TPS) for both adaptive and scheduled plans. Comparing these two data sets, we will demonstrate if patients profited from OART from dosimetrical point of view

Quelle: ClinicalTrials.gov

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